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Thermal Gradient Testing Commercial Prototype

Virginia Bio member, Thermal Gradient has received the first commercial prototypes of its FlashDirect nucleic acid (DNA/RNA) testing instrument.

The basic FlashDirect platform is idyllically suited for the point-of-care market and will be available in three variants, FlashAmp, FlashDirect-LC, and FlashDirect-HC. All three have a small footprint, perform rapid qPCR, can be wirelessly controlled by tablet, and can be optionally powered from an internal battery.

FlashAmp is a variant of the FlashDirect family that will address the non-diagnostic market. It will provide researchers with the ability to perform rapid quantitative PCR from separately prepared samples.

The FlashDirect-LC version of the instrument and cartridge is a complete sample-to-answer system that provides diagnostic results from low complexity specimens such as throat and nasal swabs, and saliva. Developed with MRSA as the primary test, the system is capable of virtually any nucleic acid based target from this class of specimen. The FlashDirect-LC platform will also be adapted for bioDefense and forensic applications.

FlashDirect-HC system provides the sample-to-answer diagnostic results from higher complexity specimens such as serum and plasma. The company has been focusing this variant on the HIV and similar testing markets.

Once the preliminary testing is complete, Thermal Gradient will refine the design and software for manufacturing and product launch.

"We are extremely excited to have reached the point where we incorporating our exceptional molecular testing capabilities in commercial products. We believe that they will make a huge difference in the point-of-care detection of HIV, Malaria, Influenza, MRSA and for other targets where high sensitivity and short test times are critically important," said CEO Robert Juncosa.